TheranosticTrials.org

Clinical Trial · NCT00310128

Combination Chemotherapy Followed by Rituximab and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed or Refractory AIDS-Related Non-Hodgkin's Lymphoma

Overview

RATIONALE: Drugs used in chemotherapy, such as etoposide, methylprednisolone, cytarabine, and cisplatin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them without harming normal cells. Giving more than one drug (combination chemotherapy) together with rituximab and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with rituximab and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed or refractory AIDS-related non-Hodgkin's lymphoma.

Sponsor

Unknown Organization

Phase

Phase 2

Contacts

Alexandra M. Levine, MD (STUDY_CHAIR)

Anil Tulpule, MD

ClinicalTrials.gov

NCT00310128

Drug / Compound

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

ibritumomab tiuxetan

Isotope(s):
Target(s):
  • cd20
Ligand Class: Antibodies
Chelator: tiuxetan

Eligibility

Inclusion

  • Primary effusion lymphoma
  • Fully recovered from all toxicities associated with prior surgery, radiotherapy, chemotherapy, or immunotherapy
  • Prior documentation of HIV seropositivity allowed
  • Karnofsky performance status 50-100%
  • Immunoblastic lymphoma
  • Received 1 prior anthracycline-based regimen of curative intent
  • Less than 25% bone marrow involvement with lymphoma
  • Negative pregnancy test
  • Anaplastic large cell lymphoma
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of study treatment
  • Histologically or cytologically documented B-cell non-Hodgkin's lymphoma, including any of the following histologic types:
  • Follicular large B-cell lymphoma (follicular, grade 3)
  • Mycobacterium avium allowed
  • Platelet count \> 75,000/mm\^3 (unless abnormal due to lymphomatous involvement of the bone marrow or HIV-related thrombocytopenia)
  • Evaluable disease defined as not having bidimensional measurements (i.e., gastric or marrow involvement) but can be followed for response by other diagnostic tests, such as gallium scan, positron emission tomography (PET) imaging and/or bone marrow biopsy
  • Measurable or evaluable disease
  • Concurrent effective highly active anti-retroviral therapy (HAART) required at study entry
  • Follicular mixed cell lymphoma (follicular, grade 2)
  • Prior chronic therapy with potentially myelosuppressive agents allowed provided hematologic criteria are met at study entry
  • Diffuse large B-cell lymphoma
  • Creatinine \< 2.0 mg/dL (\< 2.6 mg/dL if due to use of tenofovir or truvada) OR creatinine clearance ≥ 60 mL/min
  • Seropositive for HIV by any approved test or positive HIV-1 RNA in plasma at anytime in the past
  • Bilirubin ≤ 2.0 mg/dL (unless elevated due to lymphomatous involvement of the liver or biliary tract OR due to other HIV medications \[e.g., indinavir or atazanavir\])
  • HIV viral load \< 100,000 copies/mL if HAART was not used previously
  • All stages eligible
  • Granulocyte count \> 1,000/mm\^3 (unless abnormal due to lymphomatous involvement of the bone marrow)
  • Burkitt or Burkitt-like lymphoma
  • Diffuse mixed cell lymphoma

Exclusion

  • No prior myeloablative therapies with autologous bone marrow transplantation, peripheral blood stem cell rescue, or failed stem cell collection
  • No major surgery, other than diagnostic surgery, within the past 4 weeks
  • No pegfilgrastim within 4 weeks before study radioimmunotherapy
  • No prior external beam radiotherapy to \> 25% of active bone marrow (involved field or regional)
  • No other concurrent myelosuppressive antineoplastic agents after receipt of study radioimmunotherapy until blood counts recover
  • Not pregnant or nursing
  • No zidovudine-containing regimens (including lamivudine and trizivir) during and for ≥ 2 months after completion of study radioimmunotherapy
  • No more than 1 prior regimen
  • No rituximab within 6 weeks before study radioimmunotherapy
  • No antimurine antibody (HAMA) reactivity
  • No other growth factors within 2 weeks before and after study radioimmunotherapy
  • No primary CNS lymphoma
  • No investigational agent(s) within the past 4 weeks, unless these are antiretroviral agents available on a compassionate use basis
  • No serious, ongoing nonmalignant disease or infection that would compromise study objectives
  • No acute intercurrent infection that may interfere with study participation
  • No prior radioimmunotherapy
  • No history of cutaneous or mucocutaneous reactions or diseases severe enough to cause hospitalization or an inability to eat for ≥ 2 days
  • No anticancer therapy within the past 3 weeks (6 weeks for nitrosourea or mitomycin C)
  • No history of any cutaneous or mucocutaneous reaction from prior rituximab administration
  • No radiotherapy within the past 4 weeks, unless for emergency conditions secondary to lymphoma (i.e., cord compression)